Breast implants are prosthetic devices that are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation mammoplasty) or to rebuild breast tissue after mastectomy or other damage to the breast (breast reconstruction). They are also used in revision surgeries, which correct or improve the result of an original surgery.
There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. They vary in size, shell thickness, shell surface texture, and shape (contour).
There are several important things to consider before deciding to undergo breast implant surgery, including understanding your own personal expectations and reasons for having the surgery. Below are some things the FDA thinks you should consider before undergoing breast augmentation, reconstruction or revision surgery.
- Breast implants are not lifetime devices; the longer you have your implants, the more likely it will be for you to have them removed.
- The longer you have breast implants, the more likely you are to experience local complications and adverse outcomes.
- The most common local complications and adverse outcomes are capsular contracture,
reoperation, implant removal, and rupture or deflation of the implant. Other complications include wrinkling, asymmetry, scarring, pain, and infection at the incision site. - You should assume that you will need to have additional surgeries (reoperations).
- Many of the changes to your breast following implantation may be cosmetically undesirable and irreversible.
- If you have your implants removed but not replaced, you may experience changes to your natural breasts such as dimpling, puckering, wrinkling, breast tissue loss or other undesirable cosmetic changes.
- If you have breast implants, you will need to monitor your breasts for the rest of your life. If you notice any abnormal changes in your breasts, you will need to see a doctor promptly.
- If you have silicone gel-filled breast implants, you will need to undergo periodic MRI examinations in order to detect ruptures of the implant that do not cause symptoms (“silent ruptures”). For early detection of silent rupture, the FDA and breast implant manufacturers recommend that women with silicone gel-filled breast implants receive MRI screenings 3 years after they receive a new implant and every 2 years after that. MRI screening for implant rupture is costly and may not be covered by your insurance.
- If you have breast implants, you have a low risk of developing a rare type of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in the breast tissue surrounding the implant. BIA-ALCL is not breast cancer. Women diagnosed with BIA-ALCL may need to be treated with surgery, chemotherapy and/or radiation therapy.
For more detailed information about breast implants, visit www.fda.gov/breastimplants
